Impact of highly active anti-retroviral therapy (HAART) during pregnancy and breastfeeding on mother-to-child transmission (MTCT) and mother's health

Completed

• Conditions: Human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS); Infections and Infestations; Human immunodeficiency virus (HIV)

• Registration Number: ISRCTN71468401
• Lead Sponsor: World Health Organization (WHO) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2400

Inclusion Criteria

1. Pregnant, with a gestational age of 28 - 34 weeks (or between 16 and 32 weeks gestation if the woman is referred with medically-documented HIV stage four [clinical AIDS] or CD4+ cell count below 200 cells/mm^3 diagnosed before study screening)
2. No evidence of clinically-significant conditions likely to require specific care arrangements and which may interfere with study interventions (obstetric, cardiac, respiratory [including active tuberculosis], hepatic, gastrointestinal, endocrine, renal, haematologic, psychiatric, neurologic, or allergic) as assessed by the study site Principal Investigator
3. Confirmation of HIV infection at the study site
4. Not having received an HIV vaccine (never enrolled in an HIV-vaccine trial)
5. Willingness to receive, and no contraindication to receive, the short MTCT-prophylaxis regimen as a minimum
6. No previous enrolment in the Kesho Bora study
7. Capacity and willingness to participate in all follow-up visits, including participating in all clinical examinations, having blood drawn, as well as willingness for their infant to be clinically and physically examined and have blood drawn
8. Residing, and planning to continue to reside, within a predefined, site-specific catchment area until two years after delivery
9. Ability and willingness to give informed consent for enrolment in the study
10. Not currently taking Anti-RetroViral drugs (ARV) drugs

Women who meet the above eligibility criteria will be invited to enrol in the study (Part I). Those who, in addition, meet WHO criteria for initiating HAART, have no contraindications to HAART and accept HAART will be enrolled in Part IA and will receive HAART. All other women will be enrolled in Part IB and will receive the short-course MTCT prophylaxis. This includes women not meeting WHO criteria for treatment, having a contraindication to HAART, or refusing HAART. Additional eligibility criteria for women in Part IB to be enrolled in the randomised controlled trial (Part II) are:
1. Not meeting WHO clinical criteria for treatment
2. Having CD4+ cell count between 200 and 500 cells/mm^3
3. Having no contraindication to the triple-ARV MTCT-prophylaxis regimen
4. Willing to be randomised to receive the triple-ARV or short-course MTCT-prophylaxis regimen

Exclusion Criteria

Does not comply with the inclusion criteria above.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. HIV-free infant survival at 6 weeks and 12 months <br>2. AIDS-free survival among mothers by 12 months postpartum<br>3. Incidence of severe adverse events in mothers